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• W2892373904 abstract "7541 Background: ECHELON-1 is a global, phase 3 study of BV plus doxorubicin, vinblastine, and dacarbazine (A+AVD) vs ABVD as frontline therapy in patients with advanced HL (NCT01712490). The primary endpoint was modified PFS (mPFS) per independent review facility (IRF) defined as progression (PD), death, or the receipt of additional treatment for patients not achieving CR at the completion of frontline therapy. A+AVD was superior to ABVD (HR = 0.77, p = 0.035) with 2-year mPFS rates of 82.1% and 77.2%; as previously reported. Methods: Efficacy and safety of A+AVD vs ABVD in North America (NA) was examined. mPFS in NA was a prespecified analysis. Traditional PFS by investigator, where only PD or death were counted as events, was a sensitivity analysis of the primary endpoint. Results: 497 pts in NA with advanced classical HL were randomized 1:1 to receive up to six cycles of A+AVD or ABVD. There was a significant improvement in mPFS by IRF and by INV for pts who received A+AVD compared with ABVD (Table). 2-year traditional PFS by INV was also improved with A+AVD. Across subgroups, a benefit for A+AVD was consistently observed, including in pts with Stage III (HR = 0.64; 95% CI: 0.33, 1.24) and Stage IV (HR = 0.55; 95% CI: 0.33, 0.94) disease. Clinical trial information: NCT01712490. Adverse event rates for A+AVD vs ABVD (all grades) were: interstitial lung disease 3% vs 10%, peripheral neuropathy, 80% vs 56%; neutropenia, 62% vs 54%; febrile neutropenia (FN), 20% vs 9%. In A+AVD pts receiving G-CSF primary prophylaxis, FN was 9%. Two NA pts died during treatment with A+AVD vs 7 with ABVD. Conclusions: For pts treated in NA on the ECHELON-1 trial, the absolute difference between A+AVD and ABVD at 2 years for mPFS by IRF was 10.6% and for PFS by INV was 11.7%. A prospective clinical trial is planned to confirm these safety and efficacy findings in advanced stage HL pts treated with A+AVD in the NA community setting. mPFS IRF mPFS INV PFS INV A+AVD ABVD A+AVD ABVD A+AVD ABVD N 250 247 250 247 250 247 2-year survival (%) 84.3 73.7 86.4 73.6 88.1 76.4 HR (95% CI) 0.60 (0.40,0.90) 0.52 (0.34, 0.79) 0.50 (0.32-0.79) p-value 0.012 0.002 0.002" @default.
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• W2892373904 date "2018-05-20" @default.
• W2892373904 modified "2023-10-15" @default.
• W2892373904 title "Brentuximab vedotin (BV) plus chemotherapy in patients with newly diagnosed advanced stage Hodgkin lymphoma (HL): North American results." @default.
• W2892373904 doi "https://doi.org/10.1200/jco.2018.36.15_suppl.7541" @default.
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